Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT05717634
  4. Details
NCT05717634 Clinical Trial

Endometrial Changes in Breast Cancer Women.

Breast Cancer Clinical Trial

Official title:
Endometrial Changes in Breast Cancer Women: a Prospective Multicentric Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05717634
Other study ID # Regina Elena
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 26, 2023
Est. completion date January 26, 2024

Study information
Verified date January 2023
Source Regina Elena Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Description:

This is a prospective observational multicentric study. Patient with a history of breast cancer treated with adjuvant hormonal therapies or with no therapies, will be enrolled and followed once a year with physical exam and endovaginal ultrasound. Patients with suspected endometrial pathology will undergo hysteroscopy with endometrial biopsy or endometrial lesion resection. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 829
Est. completion date January 26, 2024
Est. primary completion date September 26, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Personal history of breast cancer Exclusion Criteria: - Personal history of other hormonal sensitive cancers - Assumption of hormones in the previous 5 years - Previous medical assisted reproduction technique - Lynch syndrome or BRCA 1/2 mutations

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Hysteroscopy
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.

Locations
Country Name City State
Italy IRCCS "Regina Elena" National Cancer Institute Rome Lazio

Sponsors (8)
Lead Sponsor Collaborator
Regina Elena Cancer Institute Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, Universita di Verona, University of Messina, University of Padova, University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of endometrial cancer Evaluation of the incidence of endometrial cancer and atypical hyperplasya One year
Secondary Ultrasonographic soft markers of endometrial pathology Identification of ultrasonographic soft markers of endometrial pathology One year
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A